Assessing the usability of wireless thermal devices for hydrocephalus management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on evaluating the usability of wireless thermal anisotropy devices designed for measuring shunt flow in patients with hydrocephalus. Participants will undergo non-invasive measurements while their interactions with the device are observed, and their understanding will be assessed through comprehension questions. The data collected will inform future improvements in device design to enhance patient care and usability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject or caregiver can clearly communicate and document information in English
4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
5. Subject is at least 5 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of an interfering open wound in the device application region
2. Subject-reported history of adverse skin reactions to adhesives

Where it's running

• Rhaeos, Inc.
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Anna Somera
• Email: info@rhaeos.com
• Phone: 855-814-3569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wearable sensor to detect CSF flow in shunt tubing

  This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.

  Recruiting Rhaeos, Inc. · Peoria, Illinois · NCT07478926

• CSF lactate and other biomarkers in patients with an external ventricular drain after acute brain injury

  This project will test whether changes in cerebrospinal fluid lactate and other blood/CSF biomarkers can help detect ventriculostomy-associated infection in adults with acute brain injury who have an external ventricular drain.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07380477

• See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep

  A wireless thermal device is being tested to see if it can non-invasively monitor CSF shunt flow in people with hydrocephalus during everyday activities and sleep.

  Recruiting at 2 sites Rhaeos, Inc. · Chicago, Illinois and 1 other locations · NCT07050628

• Evaluating a device for measuring cerebrospinal fluid flow and headaches

  This study is testing a new device that measures the flow of cerebrospinal fluid in people with hydrocephalus to see if it can help understand their headaches better.

  Recruiting Rhaeos, Inc. · Chicago, Illinois · NCT06996600

• Understanding brain and heart injuries after bleeding in the brain

  This study looks at how bleeding in the brain affects both the brain and the heart in adults to better understand the connection between these injuries.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT06906432

• Light therapy for severe neonatal brain bleeding

  This study is testing if a special light therapy can help newborns with severe brain bleeding feel better and develop normally over time.

  Recruiting at 2 sites Rutgers, The State University of New Jersey · Newark, New Jersey and 1 other locations · NCT06797219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.